Related Pages Protecting Participants in Clinical Trials A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.

Selected Bibliography

Advisory Committee on Human Radiation Experiments. The Human Radiation Experiments. New York: Oxford University Press, Inc., 1996.

Beauchamp T, Childress J. Principles of Biomedical Ethics. Third Edition. New York: Oxford University Press, Inc., 1989.

Buchanan A, Brock D. Deciding for Others: The Ethics of Surrogate Decision Making. New York and Cambridge: Cambridge University Free Press, 1995.

Bursztajn H, Feinbloom R, Hamm R, et al. Medical Choices, Medical Chances: How Patients, Families, and Physicians Can Cope with Uncertainty. New York: Free Press, 1984.

Davis T, Holcombe R, Berkel H, et al. Informed consent for clinical trials: A comparative study of standard versus simplified forms. JNCI 1998;90:668­74.

Doak C, Doak L, Root J. Teaching Patients with Low Literacy Skills. Second Edition. New York: Lippincott, 1996.

Doak L, Doak C, Meade C. Strategies to improve cancer education materials. Onc Nursing Forum, 1996;23:1305­12.

Doak C, Doak L, Friedell G, et al. Improving comprehension for cancer patients with low literacy skills: Strategies for clinicians. CA-A Can J for Clinicians 1998;48:151­62.

Dworkin G. Autonomy and informed consent. The Theory and Practice of Autonomy. New York: Cambridge University Press, 1988.

Engelhardt T. The Foundations of Bioethics. Oxford: Oxford University Press, Inc., 1996.

Faden R, Beauchamp T. A History and Theory of Informed Consent. New York: Oxford University Press, Inc., 1986.

Federal Policy For The Protection Of Human Subjects. (Common rule). Federal Register 1991;56:28002.

Freeman W. Making research consent forms informative and understandable: The experience of the Indian Health Service. Camb Q Healthc Ethics 1994;3:512­21.

Gostin L. Informed consent, cultural sensitivity and respect for persons. JAMA 1995;274:844­5.

Grossman S, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncology 1994;12:2211­5.

Hochhauser M. Some overlooked aspects of consent form readability. IRB: A Review Of Human Subjects Research 1997;19:5­9.

Joseph R. Viewpoints and concerns of a clinical trial participant. Cancer 1994;74:2692­3.

Katz J. Experimentation with Human Beings. New York: Russell Sage Foundation, 1972.

Katz J. The Silent World of Doctor and Patient. New York: Free Press, Macmillan Inc., 1984.

Levine R. Ethics and Regulation of Clinical Research. New Haven and London: Yale University Press, 1998.

Meade C, Howser D. Consent forms: How to determine and improve their readability. Onc Nursing Forum 1992;19:1523­8.

Miller S. Monitoring versus blunting styles of coping with cancer influence the information patients want and need about their disease. Cancer 1995;76:177­97.

Olver I, Buchanan L, Laidlaw C, et al. The adequacy of consent forms for informing patients entering oncological clinical trials. Ann Onc 1995;6:867­70.

Office for Protection from Research Risks, Protecting Human Research Subjects, Institutional Review Board Guidebook, 1993.

Prentice E, Gordan B, Gwenn, O, et al. Informed consent in oncology clinical trials. Can Mgmt July/August 1997;6­11.

Porter J. Basic considerations in informed consent in research. Clinical Research and Regulatory Affairs 1995;12:95­109.

Savulescu J, Momeyer R. Should informed consent be based on rational beliefs? J Med Ethics 1997;23:282­8.

Schafer A. The ethics of the randomized clinical trial. N Engl J Med 1982;307:719­24.

Sulmasy D, Lehmann, L, Levine, D, et al. Patients' perceptions of the quality of informed consent for common medical procedures. J Clin Ethics1994;5:189­94.

Tabak N. Decision making in consenting to experimental therapy. Cancer Nursing1995;18:89­96.

Titus S, Keane M. Do you understand? An ethical assessment of researchers' description of the consenting process. J Clin Ethics 1996;7:60­8.

Vanderpool H, ed. The Ethics Of Research Involving Human Subjects: Facing the 21st Century. Frederick, MD: University Publishing Group, 1996.

Veatch R. The Patient as Partner: A Theory of Human Experimentation Ethics. Bloomington and Indianapolis: Indiana University Free Press, 1987.

Veatch R, ed. Medical Ethics. Second Edition. Sudbury, MA: Jones and Bartlett Publishers, 1997.

Department of Health and Human Services, Federal Register 56. June 18, 1991;CFR46:101­46, 124.

Food and Drug Administration, Department of Health and Human Services, Federal Register 45. May 30, 1980;21CFR50:20­50,27;56:109.

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